Guided Needle Insertion for Vascular Access

The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment.

Males or females with end-stage kidney disease who are 18 and older and not pregnant or breastfeeding can be included in the study.

The main question it aims to answer is:

Can the study device guide the cannulator to the arteriovenous fistula (AVF) or arteriovenous graft (AVG) and assist the cannulator with needle insertion into the AVF or AVG for dialysis cannulation?

Completed

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Key information

Conditions

End Stage Renal Failure, Hemodialysis Cannulation Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 1

Tashkent, Uzbekistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males or non-pregnant, non-breastfeeding females ≥ 18 years of age
Presence of an AVG/AVF access site in the forearm or upper arm
AVF is actively used for dialysis treatment
AVF diameter is between 8 mm and 12mm, confirmed by ultrasound
AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound
Able to report their pain using a validated pain scale.
Able and willing to provide written informed consent.

Exclusion criteria

Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF/AVG access site
Presence of a condition or impediment that may interfere with ultrasound imaging

Treatment and study plan

Ultrasound-Guided, Power-Assisted Needle Insertion

Device

Device Intervention

Primary outcomes

Proportion of investigational device cannulations in which successful cannulation of the AVF/AVG is achieved within a maximum of three attempts, confirmed by blood flashback and ability to proceed with dialysis.

Time frame: 1 week

Sponsors and collaborators

Lead sponsor

X9, Inc.

Industry

Registry information

Official study title

Ultrasound-Guided Power-Assisted Needle Insertion for Vascular Access Study

Acronym: ACCESS 2

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 23, 2026
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed